Certified Lead Implementer - ISO 15189 Medical Laboratories - Quality Management System

Lead Implementer - ISO 15189:2012

• This course is designed to enable professionals to build capability to initiate and spearhead the Implementation of ISO 15189 in medical laboratories. A robust quality management system will boost the medical laboratory’s credibility rating; opening up new business avenues & propelling it towards greater success.
• You will attain the skills to evaluate a laboratory’s current processes, equipment, personnel & service quality. You will establish an effective quality management system compliant to ISO 15189 in the laboratory, conduct audits, review audit data, communicate results & propose corrective actions. You will be responsible in ensuring that the laboratory renders accurate & valid medical test results in a timely manner. You will further ensure that the laboratory maintains its compliance to ISO 15189.
• Empirical approach to coaching will include detailed training material, assignments, case studies and presentations to assist students in analysis and synthesis of body of knowledge and to develop required skills.
• On course completion, you can appear for the exam to qualify for Credentials Global’s ISO 15189 Lead Implementer certification.
• This course is open to all professionals, operation managers, compliance executives, health specialists, and senior management that wish to lead the implementation of and establish conformity with the ISO 15189 framework.

Key Outcomes:

• Appreciate the significance of an ISO 15189 audit
• Acknowledge that ISO 15189 standard provides a structured approach to streamline key laboratory processes like inquiries, registrations, & requests, managing patients, collecting samples, safeguarding patient information, transport, storage, reviews
• Understand key implementation techniques & requirements for assisting the laboratory in achieving compliance with ISO 15189
• Identify the correlations between ISO 15189& other regulatory & legal frameworks
• Develop competence to lead the implementation of a ISO 15189 audit
• Review audit discoveries and suggest remedial measures to upgrade a laboratory’s quality management system
• Guide clients to achieve& maintain compliance with ISO 15189 framework

Course Chapters:

Chapter 1 Introduction to Course
Chapter 2 Introduction to Standard & Terms and Definition
Chapter 3 Quality Related Concepts
Chapter 4 Process Mapping
Chapter 5 Conformity Assessment
Chapter 6 Organization & Management Responsibility
Chapter 7 Quality Management system and Document Control
Chapter 8 Service Agreements & Examination by referral laboratories
Chapter 9 External Services & Suppliers
Chapter 10 Advisory Services & Resolution of Complaint
Chapter 11 Non conformities & CAPA
Chapter 12 Continual Improvement and Control of Records
Chapter 13 Evaluation & Audits
Chapter 14 Management Review
Chapter 15 Personnel
Chapter 16 Accommodation & Environment
Chapter 17 Equipments Reagents & Consumables
Chapter 18 Process Control
Chapter 19 Quality Control
Chapter 20 EQA
Chapter 21 Laboratory Information Management System
Chapter 22 Managing Management System Implementation Project
Chapter 23 Consulting Skills for Management System Implementation

Certified Lead Implementer - ISO 15189 Medical Laboratories - Quality Management System etraining online Course

What is the course attendance criteria?

• A minimum attendance of 80 hrs on Learning Management System (LMS) activity for the duration of course is required.
• However, we encourage students to log in maximum number of hrs within a given course duration to take maximum benefit of learning material.

How assignments will be evaluated/graded?

• Assignments will not be graded.
• Assignments will consist of Descriptive Type Questions and Case Studies.

What is the nature of qualifying examination?

• Qualifying examination consist of Multiple Choice Questions.

What is the examination eligibility criteria?

• An open book test can be scheduled once student completes minimum 80 hrs on LMS and completes all given Assignments.

How assignments will be evaluated/graded?

• Assignments will not be graded.
• Assignments will consist of Multiple Choice Questions, True or False, Match the Pairs, Descriptive Types and Case Studies.
• Only Multiple Choice Questions- Auto Diagnostics Feedback is given.

How examination results are presented?

• The designations P (Pass) and NP (Not Pass) are used. No grades are reported.

What are the examination pass norm?

• It is expected that at least 80% of students attending this course should pass at first attempt.

What are the documents permitted during the open book examination?

• Course material
• Copy of ISO 15189 standard
• Copy of ISO 19011 standard

What is the certification policy?

• Certification will be given to student who completes all assignments satisfactorily and clears the examination with the designation P.
• Certification of successful completion are endorsed with the Credentials Global logo and ACCAB’s “Responsible Education Provider”™ Logo
• Student who does not qualify for certificate of successful completion may be awarded a letter of attendance.

What is the re-examination policy?

• A student who gets a letter of attendance after the initial course may apply to be allowed to sit for a re-examination within 1 month from the issuing of the results. A candidate who fails re-examination is required to take the course again paying full fees.

What is complaints and appeals policy?

• Student May raise any complaint in writing or orally, both during the course and afterward. Student is also given the opportunity to raise any issues of the concern during the formal evaluation at the end of the course.
• Contact information: Info@credentialsglobal.com

Do I receive Professional Development Units (PDUs) for the course?

• Yes, 40 PDUs

Is this course accredited?

The Credentials Global education provider accredited with the Accreditation Commission of Conformity Assessment Bodies (ACCAB) www.accab.org

ACCAB’s "Responsible Education Provider"™ Accreditation is a voluntary quality assurance scheme for independent private sector Further Education & Training Institutions(FETIs) including Independent Higher Education Providers, Distance Learning Institutions, Professional Short Course Providers and Specialty Tutorial Schools & Colleges.

The objectives of ACCAB’s “Responsible Education Provider”™ Accreditation Scheme are:

• FETIs have appropriate management systems in place and control over their processes;
• Personnel that are employed by FETIs have required competencies to perform their duties;
• FETIs follow rigorous and consistent processes to educate, train and evaluate students;
• To enable FETIs to state publicly that they have voluntary accepted ACCAB’s “Responsible Education Provider”™ Accreditation Scheme for maintenance and continual improvement of their services delivery.